Wounds and InjuriesPhase 1NCT06121661
APPRAISE 2.0: Live Trial of the APPRAISE Trauma Decision Support System
A Phase 1 study testing APPRAISE Trauma Clinical Decision Support System in people with Wounds and Injuries, run by Andrew Tomas Reisner at 1 site in United States.
Trial summary
This is a pilot evaluation of the APPRAISE trauma decision-support software system ("the System"). The specific objections are as follows: 1. Evaluate the robustness of the System (i.e., whether the software performs in real-time in accordance with a priori technical specifications during real-time clinical use); 2. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Wounds and Injuries
- What is being tested?
- APPRAISE Trauma Clinical Decision Support System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Feb 2023to 14 Dec 2028
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult (≥18 yrs) Emergency Department (ED) patient
- Triaged to the "Acute" area of the ED. (The "Acute" area is the designated area for ED patients with potential or established critical illness. Triage to Acute is a routine ED operation that is performed based on departmental guidelines and the professional judgement of an experienced triage nurse).
- Clinical concern for acute injury (based on either an explicitly chief complaint of acute injury, or clinical team with documented concern for acute injury as a relevant part of patient presentation).
Who cannot join
- Prisoners
- Patients known to be pregnant, based on patient report, physical exam, or bedside ultrasound
- Patients wearing an "EFIC Opt-Out" bracelet
- Any concern about the suitability of the software system for a specific patient by any clinician involved in the patient's ED care, or by the patient themselves (or by any LAR [lawfully authorized representative] of the patient).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Massachusetts General Hospital
Boston, Massachusetts, 02460
Andrew T Reisner, 6177262241, areisner@mgh.harvard.edu
About this study
This is a pilot evaluation of the APPRAISE trauma decision-support software system ("the System"). The specific objections are as follows:
- Evaluate the robustness of the System (i.e., whether the software performs in real-time in accordance with a priori technical specifications during real-time clinical use);
- Evaluate whether the real-time display of the System causes distraction or confusion to clinicians treating the trauma patient such that its risks exceed its benefits;
- Collect pilot data to allow for a statistical power analysis to design a future clinical trial evaluating efficacy.
- Conditions
- Wounds and Injuries
- Being tested
- APPRAISE Trauma Clinical Decision Support System
- Medical subject headings
- Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
APPRAISE Trauma Clinical Decision Support SystemDevice
Real-time bedside decision-support system for trauma patient management
| Study group | Role | What they receive |
|---|---|---|
| APPRAISE cases | Experimental | Trauma patients for which APPRAISE system was used Receives: Device: APPRAISE Trauma Clinical Decision Support System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Software session with error messages or critical software errors
Each time the software is used ("session"), a log file is generated. We will quantify how many sessions generate error messages or critical software errors.
Measured: From patient arrival in the Emergency Department through enrollment, protocol initiation, and protocol completion (which is typically 30 min after protocol initiation).
Clinician surveys that the software negatively affected patient care
Each time the software is used, clinicians are surveyed whether the software negatively affected patient care, in their professional judgement
Measured: From patient arrival in the Emergency Department through enrollment, protocol initiation, and protocol completion (which is typically 30 min after protocol initiation)
Clinician surveys that the software positively affected patient care
Each time the software is used, clinicians are surveyed whether the software negatively affected patient care, in their professional judgement
Measured: From patient arrival in the Emergency Department through enrollment, protocol initiation, and protocol completion (which is typically 30 min after protocol initiation)
Clinician surveys that ongoing use of the software poses risks that exceeds benefits
Each time the software is used, clinicians are surveyed whether ongoing use of the software poses risks that exceeds benefits
Measured: From patient arrival in the Emergency Department through enrollment, protocol initiation, and protocol completion (which is typically 30 min after protocol initiation)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2023
- Study start21 Feb 2023
- Primary completion14 Dec 2027 (estimated)
- Study completion14 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Wounds and InjuriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Andrew Tomas Reisner
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Andrew Tomas Reisner, Massachusetts General Hospital
- Investigators
- Andrew Reisner, MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06121661
- Sponsor's protocol ID
- 2022P001136
- Status last verified
- Oct 2026
- First submitted
- 18 Oct 2023
- Last updated
- 29 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- APPRAISE 2.0: Live Trial of the APPRAISE Trauma Decision Support System
- ClinicalTrials.gov ID
- NCT06121661
- Acronym / sponsor ID
- 2022P001136
- Conditions
- Wounds and Injuries
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Andrew Tomas ReisnerUniversity, hospital or other
- Study start
- 21 Feb 2023 (actual)
- Primary completion
- 14 Dec 2027 (estimated)
- Study completion
- 14 Dec 2028 (estimated)
- First posted
- 8 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a pilot evaluation of the APPRAISE trauma decision-support software system ("the System"). The specific objections are as follows:
- Evaluate the robustness of the System (i.e., whether the software performs in real-time in accordance with a priori technical specifications during real-time clinical use);
- Evaluate whether the real-time display of the System causes distraction or confusion to clinicians treating the trauma patient such that its risks exceed its benefits;
- Collect pilot data to allow for a statistical power analysis to design a future clinical trial evaluating efficacy.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| APPRAISE cases | Experimental | Device: APPRAISE Trauma Clinical Decision Support SystemTrauma patients for which APPRAISE system was used |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult (≥18 yrs) Emergency Department (ED) patient
- Triaged to the "Acute" area of the ED. (The "Acute" area is the designated area for ED patients with potential or established critical illness. Triage to Acute is a routine ED operation that is performed based on departmental guidelines and the professional judgement of an experienced triage nurse).
- Clinical concern for acute injury (based on either an explicitly chief complaint of acute injury, or clinical team with documented concern for acute injury as a relevant part of patient presentation).
Key exclusion criteria (4 listed)
- Prisoners
- Patients known to be pregnant, based on patient report, physical exam, or bedside ultrasound
- Patients wearing an "EFIC Opt-Out" bracelet
- Any concern about the suitability of the software system for a specific patient by any clinician involved in the patient's ED care, or by the patient themselves (or by any LAR [lawfully authorized representative] of the patient).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| APPRAISE Trauma Clinical Decision Support SystemReal-time bedside decision-support system for trauma patient management | Device | APPRAISE cases |
Primary outcome
Software session with error messages or critical software errors
Time frame: From patient arrival in the Emergency Department through enrollment, protocol initiation, and protocol completion (which is typically 30 min after protocol initiation).
Each time the software is used ("session"), a log file is generated. We will quantify how many sessions generate error messages or critical software errors.
Clinician surveys that the software negatively affected patient care
Time frame: From patient arrival in the Emergency Department through enrollment, protocol initiation, and protocol completion (which is typically 30 min after protocol initiation)
Each time the software is used, clinicians are surveyed whether the software negatively affected patient care, in their professional judgement
Clinician surveys that the software positively affected patient care
Time frame: From patient arrival in the Emergency Department through enrollment, protocol initiation, and protocol completion (which is typically 30 min after protocol initiation)
Each time the software is used, clinicians are surveyed whether the software negatively affected patient care, in their professional judgement
Clinician surveys that ongoing use of the software poses risks that exceeds benefits
Time frame: From patient arrival in the Emergency Department through enrollment, protocol initiation, and protocol completion (which is typically 30 min after protocol initiation)
Each time the software is used, clinicians are surveyed whether ongoing use of the software poses risks that exceeds benefits
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Andrew Reisner, MD principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing APPRAISE Trauma Clinical Decision Support System in people with Wounds and Injuries, run by Andrew Tomas Reisner at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yang Wang (6177262241, YWANG132@mgh.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Software session with error messages or critical software errors (time frame: From patient arrival in the Emergency Department through enrollment, protocol initiation, and protocol completion (which is typically 30 min after protocol initiation).). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2026.